Clinical trial · Interventional
RCT on the Efficacy of Methotrexate for the Prevention of GTD
The Efficacy of Methotrexate for the Prevention of Postmolar Gestational Trophoblastic Disease Among Patients With High-Risk Hydatidiform Mole
NCT01984099CI-TRIAL-00044711completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A randomized, controlled trial to evaluate the efficacy of methotrexate for the prevention of postmolar gestational trophoblastic disease among patients with high-risk hydatidiform mole.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hydatidiform Mole | Molar Pregnancy | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methotrexate | Drug | Methotrexate | ALIAS |
| Vitamin B Complex | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Chemoprohylaxis Group
- description
- Chemoprohylaxis Group: the treatment group, will be given a single course of methotrexate within fourteen days from molar evacuation. Methotrexate will be given at 0.4 mg/kg intramuscularly per day for 5 days. No chemotherapy will be administered if the hemoglobin is lower than 10 g/L, WBC is less than 3.0 x 10 g/L or more than 10.0 x 10 g/L, absolute neutrophil count is less than 1.5, platelet count is lower than 100,000/cu.cc., patient has elevated liver and renal function test and has concurrent infection.
- interventionNames
- Drug: Methotrexate
- type
- PLACEBO_COMPARATOR
- label
- Control Group
- description
- Control Group: will be given a placebo in a form of Vitamin B Complex (Bee ALL), intramuscularly or intravenously.
- interventionNames
- Drug: Vitamin B Complex
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * diagnosis and molar evacuation done at the Department of Obstetrics and Gynecology of the Philippine General Hospital; * patients who will undergo suction curettage for evacuation of molar pregnancy; * histopathologically confirmed complete hydatidiform mole; * must have at least one of the following risk factors for the development of postmolar gestational trophoblastic disease: * uterine size larger than age of gestation of more than 6 weeks * serum B-hCG titer more than or equal to 100,000 mlU/ml * theca lutein cysts more than or equal to 6 cms in size * gravidity of 4 or more * recurrent molar pregnancy * medical complications arising from trophoblastic proliferation such as DIC, pre-eclampsia, thyrotoxicosis, pulmonary insufficiency * complete data; * patient must have at least one year of regular follow-up and hCG monitoring following onset of remission; * should have signed the consent form. Exclusion Criteria: * patients who are lost to follow-up or with incomplete data * patients who underwent total hysterectomy for evacuation of molar pregnancy * patients who are unable to complete the methotrexate treatment * patients who get pregnant within a year following remission * patients with a previous history of gestational trophoblastic neoplasia * patients with medical problems/complications that inhibit administration of methotrexate
References
Publications (0)
Data not yet available
No reference posted for this study.